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StrokeNCT07178535

Feasibility of Real-Time Visual Feedback in Augmented Reality to Reduce Gait Asymmetry Post-Stroke

A study testing Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality in people with Stroke, run by McGill University at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Unilateral motor deficits, such as paresis and tone disorders, are frequent consequences of stroke and lead to gait impairments. Among these, spatial asymmetry is characterized by differences in step length between the paretic and non-paretic limbs, resulting in balance problems and an increased risk of falls. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Stroke
What is being tested?
Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
15 Jan 2027to 15 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All participants must be in the subacute phase, between 14 days and 6 months following a first supratentorial stroke
  • able to walk with or without an assistive device for at least 2.5 minutes
  • present spatial asymmetry (step length ratio, SLR > 1.08)

Who cannot join

  • Abnormal or no-corrected visual acuity (EDTRS < 50/20)
  • visual field deficits (Goldmann or computerized perimetry)
  • cognitive impairment (Montreal Cognitive Assessment score < 22
  • not being able to provide informed consent
  • present other conditions besides stroke that limit walking.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anouk Lamontagne, Associate Professor contact

(450) 688-9550 ext.84168

anouk.lamontagne@mcgill.ca

Canada1 site
  • Jewish Rehabilitation Hospital - CISSS Laval

    Laval, Quebec, H7V 1R2

    Anouk Lamontagne, Associate Professor, (450) 688-9550 ext.84168, anouk.lamontagne@mcgill.ca

    Anouk Lamontagne, Associate Professor

Other trials in Canada

About this study

Official title: Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality Environment to Reduce Spatial Gait Asymmetry in Adults Post-Stroke

Unilateral motor deficits, such as paresis and tone disorders, are frequent consequences of stroke and lead to gait impairments. Among these, spatial asymmetry is characterized by differences in step length between the paretic and non-paretic limbs, resulting in balance problems and an increased risk of falls. Conventional rehabilitation has shown limited effectiveness in addressing this issue, highlighting the need for innovative approaches. Real-time feedback interventions, particularly through augmented reality (AR), may help improve gait asymmetry by providing a more natural and interactive learning environment.

This study aims to compare the effectiveness of two types of real-time visual feedback, an avatar-based system and visual bars, in improving gait symmetry and other locomotor parameters in individuals post-stroke. It will also assess the acceptability and usability of the intervention, participants' sense of presence, and the potential for cybersickness induced by these systems.

Read more

A repeated-measures design will be used to evaluate the immediate effectiveness of the two types of visual feedback on gait asymmetry and other locomotor parameters in adults in the subacute phase after stroke. Participants, aged 18 to 65 and presenting spatial asymmetry, will perform walking trials in an AR environment while being exposed to both feedback modalities in randomized order. Spatiotemporal and kinematic data will be collected using inertial sensors, while questionnaires will assess acceptability, usability, sense of presence, and cybersickness.

Participants will be evaluated in a 45-m long corridor (free of traffic) and will perform nine walking trials (three per condition) under three randomized conditions: (1) a lateral view avatar displayed on the paretic side, previously shown to provide optimal feedback on step length; (2) a visual bar feedback representing bilateral step lengths; and (3) a "control" condition with no additional feedback. Each walking trial, lasting 2.5 minutes, will consist of a pre-adaptation phase without feedback (30 s), followed by an adaptation phase with feedback (1 min), and a post-adaptation phase without feedback (1 min).

The investigators expect that avatar-based feedback will be more effective than visual bars in improving spatial symmetry. The investigators also anticipate that both feedback modalities will be well accepted and usable by participants without inducing cybersickness, but that the sense of presence will be higher with avatar-based feedback. This study will shed light on locomotor adjustment mechanisms and may lay the groundwork for future clinical trials. By offering a personalized, evidence-based approach, these results could help transform post-stroke rehabilitation through the integration of innovative tools to optimize functional recovery.

Conditions
Stroke
Being tested
Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality
Keywords
Post-stroke locomotor deficits, Spatial gait asymmetry, Real-time visual feedback, Augmented reality
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Feasibility of Two Types of Real-Time Visual Feedback in an Augmented RealityDevice

    Participants will walk in a corridor (45 m), equipped with "Xsens" inertial sensors recording their kinematics and an "HTC Vive Elite-XR" AR headset superimposing virtual feedback onto the real world. Three real-time feedback conditions (3 trials/condition) will be evaluated randomly: (1) an avatar reflecting the participant's movements; (2) visual bars indicating step lengths; (3) control condition without feedback. Participants take part in an evaluation/intervention session.

Study groups in NCT07178535
Study groupRoleWhat they receive
ParticipantExperimentalNot described
Receives: Device: Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Step length ratio

    For the ratio calculation, the mean step length values from the left and right sides will be used, with the larger value placed in the numerator to ensure that all individual ratios are >1.0. A ratio of 1.0 will indicate perfect symmetry. We will compare the step length ratio (SLR)

    Measured: For each condition the step length ratio will be assessed at each trial: before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).

Secondary outcomes (11)
  1. Walking speed

    Comparison of walking speed (product of step length and cadence) in meter per second

    Measured: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).

  2. Step width

    Comparison of step width in meter

    Measured: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).

  3. Gait cycle duration percentages

    Gait cycle duration percentages (single support phase, corresponding to the contralateral swing phase, and double support phase) in percentage

    Measured: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).

  4. Trunk and pelvis maximum range of motion

    For the trunk and pelvis, we will measure the maximum range of motion in the sagittal and frontal planes in Degree

    Measured: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).

  5. Hip and knee range of motion

    For the hip and knee, we will measure in the sagittal plane the peak extension during stance, the peak flexion during swing, and the maximum range of motion. in Degree

    Measured: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).

  6. Ankle range of motion

    For the ankle, we will measure in the sagittal plane the peak dorsiflexion at initial contact and during swing, as well as the peak plantarflexion at the end of double support uring the gait cycle. In degree

    Measured: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).

  7. Acceptability

    Participant's comments and observations collected using the Theoretical Framework of Acceptability (TFA) Questionnaire, which considers different dimensions such as affective attitude, perceived effectiveness, ethicality and opportunity cost. It comprises 8 items rated from 1 to 5. Minimum value is 8 and maximum value is 40. A higher score is associated with better outcomes.

    Measured: Investigators will compare these parameters before et after the session.

  8. Usability

    Participants' responses will be collected using the Single Ease Question (SEQ) questionnaire, which assesses task difficulty on a scale from 1 (very difficult) to 7 (very easy). The questionnaire consists of a single item, with higher scores indicating better usability.

    Measured: Investigators will compare these parameters before and after the intervention.

  9. Embodiment

    The Virtual Embodiment Questionnaire (VEQ) is a quantitative measure of the degree to which a person experiences a sense of embodiment in a virtual body within a virtual reality environment. The score is obtained by summing responses to the questionnaire items, which assess three key components of embodiment: body ownership (5 items), agency (5 items), and changes in body schema (6 items). For each item, participants indicate their level of agreement on a 7-point scale, where 1 corresponds to "strongly disagree" and 7 to "strongly agree." A higher score reflects a greater sense of virtual embodiment.

    Measured: Investigators will compare these parameters before et after the intervention.

  10. Sens of Presence

    The Holistic Presence Questionnaire (HPQ) is a quantitative measure of presence, assessing telepresence, internal and external plausibility, and perceived behavioral and cognitive affordances within a mediated environment in five items. For each item, participants indicate their level of agreement on a 7-point scale, where 1 corresponds to "strongly disagree" and 7 to "strongly agree." A higher score reflects a greater sense of presence in the virtual environment.

    Measured: Investigators will compare these parameters before et after the session.

  11. Cybersickness

    The " Fast Motion Sickness Questionnaire " is a single-item verbal self-assessment scale ranging from 0 (no cybersickness) to 20 (severe cybersickness). A higher score indicates greater cybersickness

    Measured: Investigators will compare these parameters before et after the session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2025
  2. Study start15 Jan 2027 (estimated)
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion15 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07178535
Sponsor's protocol ID
MP-50-2025-2284
Other IDs
2025-2026 - BF7 - 363369
Status last verified
Sep 2026
First submitted
3 Sep 2025
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality in people with Stroke, run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anouk Lamontagne, Associate Professor ((450) 688-9550 ext.84168, anouk.lamontagne@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Step length ratio (time frame: For each condition the step length ratio will be assessed at each trial: before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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